ConcertoTM PV-9-30-3DRecalls & reported problems
Micro Therapeutics, Inc. · COIL PV-9-30-3D V04 · Class 2 · Implant
All models of ConcertoTM (70)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536033818), received between Aug 19, 2021 and Dec 19, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Break1
- Material Deformation1
- Physical Resistance/Sticking1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2022Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THERE WERE NO ISSUES REPORTED THAT RESULTED IN THE DAMAGE THAT WAS FOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16004152 ↗MalfunctionAug 19, 2021Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking
ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE HAPPENED IN THE CATHETER LUMEN WHILE THE PHYSICIAN WAS TRYING TO REPOSITION THE COIL. IT WAS NOTED THE COIL PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12343107 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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